The U.S. Food and Drug Administration recently warned that a common gout prescription may increase your chances of death from heart-related issues.
The drug is Uloric (also known as febuxostat), which is commonly prescribed to treat gout. The FDA study concluded that Uloric has an increased risk of cardiovascular death when compared to another gout medicine, allopurinol. As a result of the study, the FDA mandated that all Uloric prescriptions include a “Boxed Warning”—the FDA’s most prominent warning—about the risks of death. Physicians and pharmacists must also give patients a Medication Guide that outlines the risks in writing when prescribing the drug.
Additionally, the FDA is now limiting its approval rating for Uloric. After this study, the FDA will only approve the prescription of Uloric if the patient did not receive effective treatment from allopurinol, or if the patient suffered severe side effects from allopurinol. Based on the results of this new study, the FDA is also warning doctors and health care professionals to only prescribe Uloric for those patients who have failed treatment under allopurinol, or those patients who cannot tolerate it. Effectively, the FDA is mandating that Uloric be only a backup plan because of the drug’s increased risk of death.
Uloric’s History and Gout.
Uloric was first approved by the FDA back in 2009 as a prescription medicine to treat gout in adults. A form of arthritis, gout occurs when uric acid (which is a substance that is naturally present in the body) builds up. This build-up of uric acid can cause swelling, redness and pain in the body’s joints. Uloric was found to be effective in lowing uric acid levels in a person’s blood, mitigating the occurrence and effects of gout.
According to the FDA, citing a National Health and Nutrition Examination Survey, gout affects about 8.3 million adults in the United States. Gout is categorized as a chronic disease, and treatment can be difficult. There are very limited prescription options for treating gout, and, according to the FDA, the means for treating this disease are unmet by currently available options.
The Study and its Findings.
When Uloric was approved in 2009, the FDA included a warning about its potential negative impact on cardiovascular health. In its “Warning and Precaution” about Uloric published alongside the drug’s approval, the FDA highlighted that a serious side effect of the drug was possible cardiovascular events, such as heart attack and stroke.
Therefore, upon the drug’s approval, the FDA also mandated that the drug’s manufacturer, Takeda Pharmaceuticals, conduct a large safety clinical trial to explore the risks of cardiovascular death from the drug. The resulting clinical trial examined more than 6,000 patients who were either taking Uloric or the alternative drug, allopurinol, to treat their gout. The results show that patients taking Uloric had an increased risk of heart-related death, as well as risk of death from all causes. The study noted patient outcomes including heart attacks, stroke, heart-related death, and unstable angina, a condition caused by insufficient blood flow to the heart.
What Should You Do If You Suffer from Gout?
If you are an adult who has been diagnosed with gout, be aware of the risk of death from the drug Uloric. Speak with your physician or health care professional about your prescription choice, particularly if you have a history of stroke or heart issues. However, if you are currently taking Uloric, the FDA warns that you should not stop without first talking to your doctor; cutting off your medication can worsen your gout.
If you are currently taking Uloric, be aware of signals of cardiovascular problems, such as irregular heartbeat, dizziness, chest pain, shortness of breath, numbness on one side of your body, rapid heartbeat or a sudden severe headache. If you experience any of these symptoms, seek emergency medical attention right away.
FDA Failed in Monitoring of Program to Curb Opioid Prescriptions
The US Food and Drug Administration (FDA) requested that drug manufacturers of long-acting opioid prescriptions pay for safety training in 2011. However, records show that the agency failed to follow up on whether the program was successful.
The goal of the program was to determine if the training for physicians who prescribed opioids was effective and to monitor other measures being taken to reduce addiction of opioid prescriptions as well as overdoses and fatalities.
A Flawed Program
According to critics, the program had a flawed design from the beginning, but it was never evaluated accurately either. Congress granted authority to the FDA back in 2007 to require training of physicians on drugs that were likely to cause addiction. The bill went into effect as a response to the oversight of the agency to monitor dangerous drugs.
Documents showed that the FDA couldn’t determine if the program was effective because the design of the studies was poor. Around 60 drugs can be included in the risk-management program. This not only includes opioids but other medications, such as isotretinoin, which is a drug to treat acne and often branded as Accutane.
Critics of the program say that the FDA allowed the pharmaceutical companies to monitor their own training. It also fails to monitor the quality of the training being given. According to a report from the Department of Health and Human Services, only about 14 percent of the programs for safety that had been reviewed by the FDA were able to meet the requirements.
The Dangers of Prescription Drugs
When it came to opioids, the requirement was that 60 percent of prescribers must take the classes, but only less than 30 percent followed through during 2012 to 2016. Even though the number of prescriptions given out was dropping, it couldn’t be determined if it was because of the training. Another issue with the program is that it didn’t provide accurate data on the correlation between the training and the reduction in overdoses and deaths. National data on overdoses had no distinction to show which doctors had taken the training and which ones hadn’t. Because of this, it was impossible to determine if the program was effective in this area.
This same problem has occurred in other programs. For instance, one program was designed to monitor the prescribing of fentanyl drugs that are to be given only to patients with cancer. While these drugs were meant only for those specific patients, many doctors prescribed the medication for other conditions.
The FDA made it a requirement for safety programs to be in place when prescribing all opioid prescriptions and not just the long-acting kinds. This change happened in 2017, but it implies that the long-acting opioids are safe for chronic pain, which goes against most research.
Prescription painkillers have been responsible for many deaths related to overdose. Doctors were prescribing these drugs at a high rate that reached its peak in 2012 at 81.3 prescriptions per 100 patients. While the rate has declined, overdosing is still a major problem in the US, especially in certain regions.
House Approves Bill Which Could Reduce Prescription Drug Prices
The House recently approved a bill that is aimed at lowering the cost of prescription medications by allowing the government to negotiate with manufacturers of the drugs.
Bill H.R. 3
The bill is titled H.R. 3 and would have a direct impact on Medicare programs. The provisions include benefits for vision, dental and hearing, and it also caps the costs Medicare beneficiaries pay out of pocket to $2000.
This bill was proposed and supported by Democrats, but the Republicans have also been working on legislation to cut prescription costs. Pharmaceutical companies oppose both this bill and the Senate bill.
One of the features of the bill includes allowing the Department of Health and Human Services to negotiate pricing for as many as 250 of the most common drugs. Manufacturers would have to provide the same prices to insurers as what was agreed upon during negotiations.
Drug manufacturers would be required to pay rebates to Medicare if prices went up faster than inflation. The Senate bill, which is sponsored and supported by Republicans, doesn’t contain the same provisions, but it does require the companies to pay rebates for raising prices above the rate of inflation.
Other Options for Legislation
Even though the Republicans didn’t agree with the Democrats’ bill, they did come up with a similar measure, which had the support of eight Democrats at the vote. It would not only cap the expenses paid out of pocket, but it would require insurance providers to provide information about medication prices to patients before they were prescribed the drugs.
The argument against the legislation to allow government to negotiate prices is that it would reduce the amount of money for research and development with pharmaceutical companies, which could limit the number of new medicines available for life-threatening illnesses. It has been estimated that the enactment of the bill would reduce the number of new drugs available by 40 for the next 20 years.
H.R. 3 allocates over $10 billion for the National Institutes of Health, which would be used for research to provide breakthrough cures. Taxpayers could save as much as $5 billion during the next ten years if it is enacted.
The rising costs of prescription medications has placed a hardship on many Americans. Some even have difficulty affording food and other necessities because of the expensive drugs they need. The situation has put pressure on lawmakers to find a solution.
Prescription manufacturers do not support the measures that limit their ability to raise prices. However, politicians recognize the need to make drugs more affordable for the average American. With another election year coming up, they are working on their campaign promises to ensure support from their constituents for the next election.
While it’s not expected for the bill to become law in its present state, there is hope that the overall goal will be met even with the changes that would be made. Some day in the future, Americans may be able to afford the drugs they need to manage their medical conditions or cure them.
FDA Tests Diabetes Drug for Carcinogen Levels
The US Food and Drug Administration is testing for the presence of certain cancer-causing chemicals in the diabetes medication metformin. This medication is a prescription drug that is given to patients with type 2 diabetes to control high blood sugar.
Continued Risks with NDMA in Drugs
Several drugs have been discovered to contain known carcinogens at levels not acceptable to the FDA in the past year. Now, metformin is under scrutiny due to the possibility that it may also contain a carcinogenic substance. The concern with these chemicals is that continued exposure could raise the risk for developing cancer in the future.
Other countries have found some metformin drugs to have low levels of N-nitrosodimethylamine or NDMA. After testing those medications, it has been determined that the level of NDMA is in the acceptable range, which is what is naturally found in food and water. However, some countries are recalling metformin medications. The US is not on that list at this time.
The FDA has a current investigation into the medication to determine if NDMA is found and whether it is above the acceptable limit of 96 nanograms per day. The agency is working with manufacturers to test the samples of the drug. If levels above 96 nanograms are found, the FDA will recommend recalls.
Experts recommend that patients continue taking the medication. If a recall is issued, the FDA will provide information to health care personnel and patients. It can be dangerous to stop taking this medication without the advice of their physician. There are no alternative medications to treat the high blood sugar in the same way.
What Does Metformin Do?
This medication works in several ways to control blood sugar in diabetics. It reduces the amount of sugar the liver makes as well as how much is absorbed throughout the body from the person’s diet. It also causes the insulin receptors in the body to be more accurate in how much insulin the system manufactures.
One of the benefits of this medication is that it doesn’t increase the amount of insulin being made in the body, which means the patient has a lower risk of hypoglycemia or low blood sugar. Other medications carry a higher risk for this condition.
The doctor may prescribe metformin in tablet form, a liquid or one of two long-acting medications. Brand names for metformin include Glucophage XR, Glumetza, Fortamet and Riomet. The medication was originally manufactured by Bristol-Myers Squibb, but several manufacturers make the generic version.
Taking a medication like metformin can control sugar levels and prevent many health issues that are related to high blood sugar. This includes diabetic neuropathy, heart disease and diabetic retinopathy. Regular use of the medication may prevent complications which arise from diabetes.
Manufacturers of metformin are working with the FDA to determine if metformin is safe for use. Anyone who is concerned about the risk of carcinogenic chemicals in this medication or other medicines should discuss the issue with their health care provider. The doctor can recommend other options or put their minds at ease.
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